European regulation of nanomaterials in biocides

What is the European regulation on nanomaterials in biocides?

By the AVICENN team – Last updated October 2023

What is a biocide?

“Biocidal” products are active substances intended to eliminate organisms “harmful” to human or animal health (insects, microbes, etc.). They cover a very wide range of products, both for industrial and domestic use: mainly household and industrial disinfectants, bactericides, fungicides, insecticides and rodenticides used both curatively (cleaning) and preventively (anti-fouling paint on boats, protection of timber, bactericide inside refrigerators).

Among the nanoparticles with biocidal activities, silver, copper, titanium dioxide and zinc oxide nanoparticles are the most frequently cited.

Pesticides for agricultural use, as well as active substances in medicines and cosmetics and in foodstuffs, are not covered by the European Biocides Regulation, as they are supposed to be covered by other European measures (which do not necessarily refer to their nanometric nature).

However, the regulation applies to products used to disinfect surfaces in contact with food and feed (equipment, containers, eating utensils, surfaces or conduits used for the production, transportation, storage or consumption of food or feed – including drinking water).

What does the Biocides Regulation say about nanomaterials?

The European Biocides Regulation No. 528/2012 was finally adopted by the Council of the European Union on May 10, 2012, to replace Directive 98/8/EC. It came into force on September 1, 2013 for a first set of active substances and in 2020 for the rest. Its provisions are directly applicable as they do not require transposition by the Member States, thus ensuring a more harmonious implementation within the EU.

The definition of nanomaterials in the Biocidal Regulation is the one recommended by the Commission in October 2011, with a threshold of 50% of particles smaller than 100 nm.

Article 58 requires (nano) labeling: “The label shall include (…) the name of all nanomaterials contained in biocidal products, followed by the word “nano” in parentheses.

Because of the specific risks raised by nanomaterials when used as biocides (nano-silver, zinc oxide nanoparticles, copper oxide, etc.), the Biocides Regulation specifies separate safety controls and labels for products containing nanomaterials:

• Article 69 requests that the label should not only indicate (nano) behind the name of the biocidal nanomaterials but also “any specific risks associated with it”. This provision is a first of its kind as the labeling requirements laid down by other European texts are currently limited to the mention of the term “nano” only. It remains to be seen if and how this is put into practice.
• As the risks of nanomaterials have not yet been properly assessed, biocides containing nanomaterials require a specific authorization.

A major problem is that the labeling requirement only applies to biocidal products for which biocidal priorities are claimed. This means that biocidal nanoparticles can be used without a marketing authorization or a mention (nano) on the label, as long as they are not being promoted as biocidal by the product manufacturer.

How is it implemented?

Few marketing authorizations

Up to now, according to the report on the implementation of Regulation (EU) No. 528/2012 concerning the marketing and use of biocidal products (published in June 2021):

• only two biocidal active substances that are nanomaterials have been approved:
  • pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide
  • and synthetic amorphous silicon dioxide (nano).
• only one product has been authorized in 11 Member States: Synthetic amorphous silicon dioxide (nano ) (for this product, it has been concluded that no exposure to primary particles at the nanoscale is expected during its use).

We do not know which are the two other active nanomaterial substances included in the review program (in 2020, the application for authorization of one of them was rejected because the applicant had not paid the fees).

However, the application of the regulation is still unsatisfactory

The implementation of this regulation raises many challenges – for European and national authorities as well as for the companies concerned.

– at the European level:

As soon as the Regulations came into force, the foreseeable difficulties of interpretation and application of the Regulations were pointed out by researchers¹See in particular:
– The biocides market for nano actives, Chemical Watch, May 2014: as of this date, more than 6 months after the entry into force of the Regulation, none of the 200 products containing nano-silver listed in their Danish Nanodatabase were labeled (nano)…
– EU Regulation of Nanobiocides: Challenges in Implementing the Biocidal Product Regulation (BPR), Brinch A et al, Nanomaterials, 6(2), 33, 2016.

At the end of 2016, the DGCCRF indicated²Meeting of the labelling working group – nano restriction on 22 November 2016 at the Ministry of the Environment that Synthetic amorphous silica nano dioxide was the only nano substance that had marketing authorization as of November 1, 2015³The evaluation of silica dioxide as an insecticidal active substance was finalized by ANSES in 2013, which resulted in early 2014 in its approval at the European level under the Biocides Regulation 528/2012 : COMMISSION EXECUTIVE REGULATION (EU) No 408/2014 approving synthetic amorphous silicon dioxide as an existing active substance for use in biocidal products of product-type 18, 23 April 2014.

Controls were launched at European level in March 2019; their results were published at the end of 2020⁴See in particular:
– Inspectors checking consumer products for hazardous chemicals, ECHA, March 2019;
– One-third of products claimed to be treated with biocides have incorrect labelling, ECHA, December 2020
– Report of the first harmonised project on treated articles, ECHA, BPR Subgroup of the Forum for exchange of information on enforcement – BPRS, December 2020. Silver, in nano form, is mentioned twice:

• first in the context of “authorized active substances found in the inspected articles” (table 12, page 44),
• then under “unauthorized active substances found in inspected articles” (Table 14, page 47).

In August 2021, the decision of non-approval as a biocide of silver “as a nanomaterial” was published in the Official Journal of the European Union (OJEU) for the product types 2, 4 and 9 .

The Problem is that while the Member States are in charge of controlling the proper implementation of the Regulation, they do not all have the same interpretation of the texts… and almost none of them had, until the beginning of the 2020s at least, dedicated specific means to the control of biocidal claims and applications for products containing nanomaterials.

– at the French level:

In June 2022, the General Directorate for Competition, Consumer Affairs and Fraud Control (DGCCRF) announced that it would conduct an investigation in 2021 on so-called “technical” textiles⁵Technical textiles: between innovation and overbidding, DGCCRF, 3 June 2022. Two of the six antibacterial or “anti-odor” products analyzed were treated with silver nanoparticles, which are currently being classified because of their risks… and without this information being made available to consumers, contrary to the Biocides Regulation. Following the DGCCRF’s investigation, the two operators marketing these products withdrew them from the market. To our knowledge, these were the first checks by national public authorities on the presence of biocidal nanoparticles in non-medical textiles.

To be continued…

Nano-silver free marketing?

Given the risks associated with silver nanoparticles, more and more manufacturers are using the “nano-silver free” argument as a selling point. This is the case of:

• Fisher and Paykelt ⁶The Invisible Revolution, Sustainability Council of New Zealand, May 2010, p.20. The company chose to distinguish itself from its competitor Samsung by turning its refusal to integrate silver nanoparticles in its washing machines into a sales argument; the same goes for the company Man & Machine, which promotes its keyboards and mice without nano-silver (⁷Nanoparticles: a real danger for health and the environment, press release, Man & Machine, Jan. 13. 2012). Today, many household appliances (washing machines, refrigerators in particular) and electronics (cell phone keyboards, computers, mice, etc.) are indeed coated with nanosilver. In both cases, the companies are hoping that their stated concern for human health and the environment will pay off.
• some brands of menstrual panties⁸EU biocides law considered a “standstill” by NGOs, Pesticide Action Network (Germany, Europe, UK), Health & Environment Alliance (HEA), and Women in Europe for a Common Future (WECF), January 19, 2012.

More information

• European nanomaterial legislation in the past 20 years – Closing the final gaps, Nielsen MB et al., NanoImpact, 2023